BD Vacutainer® Trace Element K2 EDTA 10.8mg 368381

GUDID 50382903683814

BD Vacutainer® Trace Element K2 EDTA 10.8mg

BECTON, DICKINSON AND COMPANY

Evacuated blood collection tube IVD, K2EDTA Evacuated blood collection tube IVD, K2EDTA Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant Evacuated blood collection tube IVD, anticoagulant

• Primary Device ID: 50382903683814
• NIH Device Record Key: 8dbd66ec-ea2a-4085-92fc-e187bc391f22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® Trace Element K2 EDTA 10.8mg
• Version Model Number: 368381
• Catalog Number: 368381
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1000
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903683819 [Unit of Use]
GS1	30382903683810 [Package]; Package: Shelfpack [100 Units]; In Commercial Distribution
GS1	50382903683814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041071

FDA Product Code

• JKA: Tubes, vials, systems, serum separators, blood collection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-28

On-Brand Devices [BD Vacutainer® Trace Element K2 EDTA 10.8mg]

• 50382903683814: BD Vacutainer® Trace Element K2 EDTA 10.8mg
• 30382903683810: TUBE TRCE PLH 13X100 6.0 UPLBL R/BL EDTA